Job Title: Validation EngineerJob Description Interface with Management personnel in Engineering, Manufacturing, Regulatory Affairs, and other technical disciplines to represent QA/Validation in project teams, with the objective to assure that project quality objectives are met. Design and execute Validation Plans and Protocols for new and improved pharmaceutical manufacturing processes and products. Provide leadership and technical decision making for Management and high level technical personnel regarding cGMP compliance, regulatory issues, validation strategy, and quality systems for projects and/or strategic activities. Prepare and present technical investigative reports to Management as directed. Formulate recommendations for disposition or other actions related to product nonconformance and field performance issues. Assist in the supervision of specialized contract personnel and outside vendors in the performance of contracted services. Responsibilities + Design and execute Validation Plans and Protocols for new and improved pharmaceutical manufacturing processes and products. + Provide leadership and technical decision making for Management and high level technical personnel regarding cGMP compliance, regulatory issues, validation strategy, and quality systems for projects and/or strategic activities. + Prepare and present technical investigative reports to Management as directed. + Formulate recommendations for disposition or other actions related to product nonconformance and field performance issues. + Assist in the supervision of specialized contract personnel and outside vendors in the performance of contracted services. Essential Skills + Validation + Validation protocols + Pharmaceutical + Validation testing + Equipment validation + Computer system validation + Technical writing + Process validation + Software validation Additional Skills & Qualifications + BS degree in an engineering or scientific discipline with a minimum of five years of experience in a pharmaceutical QA/Validation Engineering position. + Certified Quality Engineer preferred. + Demonstrated knowledge within the areas of Industrial Quality Control, Quality Assurance, and Validation. + Demonstrated knowledge in Industrial Statistics and its application to Pharmaceutical Manufacturing and Quality Control. + Expertise in US FDA cGMPs as well as comparable international regulatory agency requirements for manufacturing and Quality Assurance/Control. + Knowledge in software applications supporting statistical data analysis, word processing, project management. + Familiarity and understanding of manufacturing methods related to Quality Assurance/Control, and other disciplines such as engineering, chemistry, microbiology, and sterilization assurance. Work Environment Medical device manufacturing, 100% onsite, with a team of 10 engineers. Will always be working on novel situations, new challenges, and projects. Pay and Benefits The pay range for this position is $50.00 - $60.00 Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Irvine,CA. Application Deadline This position will be accepting applications until Jan 30, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.